LAIV and EHPC
Research type
Research Study
Full title
The Effect of Live Attenuated Inactivated Influenza Vaccine on Experimental Human Pneumococcal Carriage Study KEY WORDS: mucosa, pneumococcus, influenza, carriage, colonisation, human, lung, antibody, vaccine
IRAS ID
166674
Contact name
Angela Wright
Contact email
Eudract number
2014-004634-26
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Secondary bacterial infections such as pneumococcal pneumonia are a leading cause of death during influenza epidemics. Individuals recently infected with influenza become more susceptible to pneumonia, an effect associated with increased density of pneumococcal carriage in the nose and uncontrolled inflammatory immunological responses. The interaction of influenza virus and pneumococcus has been known and well documented. Recent works have shown that the Live Attenuated Influenza Vaccine (LAIV) enhances pneumococcal carriage in murine models. These results highlighted the potential effect of mass immunization of children with LAIV on pneumococcal carriage. Increased carriage could lead to increased pneumococcal disease in LAIV-vaccinated individuals as well as increased bacterial transmission within the population. LAIV has been licensed for use in children since 2011 in Europe, and has been increasingly administered in children and adults in the USA. There is an urgent need for a clinical trial that will determine the effect of LAIV on pneumococcal carriage dynamics.
We have developed a safe and reproducible experimental human pneumococcal carriage (EHPC) model. We will use EHPC to define the effect of antecedent and concurrent LAIV on pneumococcal carriage acquisition, density and duration. We will perform two double-blind Randomised Controlled Trials (RCT) to compare LAIV with Quadrivalent Inactivated Influenza Vaccine (QIV). We will compare clinical symptoms, pneumococcal carriage density and duration associated with both vaccines administered antecedent to or concurrently with EHPC inoculation. We will investigate changes in nasopharyngeal microbiome, inflammatory responses in nasal mucosal and lung cellular immunity associated with influenza virus and pneumococcus interaction. This project may provide some reassurance regarding the impact of mass immunization with LAIV on carriage or, if carriage is increased, will provide knowledge of how a natural carriage episode might develop into pneumonia in susceptible subjects during pandemic influenza.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
14/NW/1460
Date of REC Opinion
18 Dec 2014
REC opinion
Favourable Opinion